The FDA granted a long-awaited authorization before Christmas.
WASHINGTON — The United States Food and Drug Administration (FDA) said that Buffalo, N.Y.-based 22nd Century Group can begin marketing their proprietary reduced nicotine cigarettes under the modified risk tobacco product (MRTP) regulatory pathway authorized by the Obama-era Tobacco Control Act of 2009.
“Our mission is to find ways to stop tobacco-related disease and death,” said Mitch Zeller, the director of the FDA’s Center for Tobacco Products, in a press statement on December 23, 2021.
“We know that three out of four adult smokers want to quit and the data on these products show they can help addicted adult smokers transition away from highly addictive combusted cigarettes,” said Zeller. “Having options like these products authorized today, which contain less nicotine and are reasonably likely to reduce nicotine dependence, may help adult smokers. If adult smokers were less addicted to combusted cigarettes, they would likely smoke less and may be exposed to fewer harmful chemicals that cause tobacco-related disease and death.”
On December 23, 2021, the Food and Drug Administration authorized the marketing of 22nd Century Group’s VLN King and VLN Menthol King combusted, filtered cigarettes as modified risk tobacco products. The FDA’s Center for Tobacco Products (CTP) said that they found scientific evidence that the reduced nicotine cigarettes can help reduce exposure to and the consumption of nicotine for smokers who intend to use the products.
“This order authorizing the marketing of these modified risk tobacco products does not mean FDA “approved” the products,” states a letter from the FDA sent to 22nd Century Group leadership. “Nicotine is addictive. Less nicotine does NOT
mean safer. All cigarettes can cause disease and death.”
“With 60% of adult smokers in our U.S. market research telling us they are likely to try VLN®, this is a complete game-changer for 22nd Century, the tobacco industry, public health, and adult smokers looking to change their relationship with nicotine – the addictive chemical found in all tobacco products,” said James A. Mish, chief executive officer at 22nd Century Group on Dec. 23.
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